The new survey was published online recently and will appear in the March print version of the journal Food and Chemical Toxicology. The report was the work of researchers associated with the US Army and US Navy.
Adverse events associated with numerous categories
The survey was aimed at assessing the rate of adverse events suffered by US Army, Navy, Air Force and Marine Corps service members who are using dietary supplements. The survey was distributed to about 200,000 active service members, of whom about 26,000 responded.
The authors grouped the survey results into broad categories, including pre/post workout; fat/weight loss; bodybuilding and vitamins/minerals.
The researchers fond the following prevalence of more than 1 adverse event for the following categories:
- Pre/Post workout 18.3%
- Fat/weight loss 14.8%
- Bodybuilding 9.5%
- Prohormone 8%
- Protein, amino acid 6.3%
- MVM (multivitamin, multimineral) 6%
- Multivitamin/mineral 5.6%
- Herbals 4.3%
- Joint health 2%
The study also mentions respondents’ experience with individual products. Included in that section of the study are retrospective looks at some negative episodes with supplement use in the military, including a recounting of teh DMAA affair.
Another statement in the conclusion makes it clear that the researchers started out with an assumption that supplement use can pose a danger to active duty personnel.
“The Department of Defense is aware DS use can pose a danger to SM and therefore Operation Supplement Safety (a resource maintained the Uniformed Services University) provides SMs (service members) with information on prohibited supplements and an index to check on the effectiveness and safety of DSs. This study identified AEs reported by users of specific DSs and identifies DS that may be hazardous,” they concluded.
Expert: Study’s issues limit its utility
Rick Kingston, PharmD, is a professor at the University of Minnesota as well as serving as vice president of scientific and regulatory affairs the firm SafetyCall International, which helps to manage adverse events reporting and product recalls for dietary supplement and pharmaceutical clients. As such, Kingston has experience in looking at adverse event data. The present survey has some issues that makes it difficult to say if it represents a true signal of any sort of safety problem with supplements, he said.
For starters, he said without knowing how the survey was present to SMs, it’s hard to say what biases might have been built into the reporting. Companies that conduct post-market surveillance for safety and reliability have a lot more skin in the game than do casual responders to a survey.
“The study announcement was not included so it was not clear how the study was positioned with the SMs. A study designed to study adverse effects and promoted as such would likely have bias as It would be expected that SMs that typically use or are inclined to use DS and have actually experienced adverse or side effects would agree to participate,” he said.
“Additional limitations include the fact that there was no information regarding how many stopped using the product due to the AE, what the severity of the effects were as not all AEs are created equal,” he said.
Kingston said the study also purported to find adverse events linked to substances his company is rarely called on to monitor because of their almost universal presumption of safety. It suggests concerns that his company, which now has many years of data relating to safety concerns that might arise from post-market surveillance, has not observed.
“It was also surprising to see AEs being attributed to seemingly benign supplements such as those containing echinacea, vitamin C, D, K and B Complex, 100% Whey, psyllium, milk thistle and many others.
“The data suggested that every class of product and individual product listed in their questionnaire had reported adverse effects within the limited time frame which is not consistent with other general use surveys or certainly with the data that we collect,” Kingston said.
Putting all that together, Kingston said the survey is of limited use when trying to assess supplement safety.
“Without more specificity in terms of the exact nature of the AEs, effects experienced and review of the incidents to rule out other likely contributing factors the data have limited utility,” he concluded.
Source: Food and Chemical Toxicity
Published online ahead of print doi.org/10.1016/j.fct.2022.112840
Adverse effects associated with use of specific dietary supplements: The US Military Dietary Supplement Use Study
Authors: Knapik JJ, et al.
